DFS was defined as the time from randomization to either the date of first recurrence of the disease (date as assessed by the investigator) or the date of death (whatever the cause), whichever occurred first.

Notes: -Types of recurrence to be considered as an event included loco-regional and distant metastases. -In addition, any death occurring without prior documentation of tumor recurrence was considered as an event (and was not censored in the statistical analysis) as this approach was less prone to introduce bias. -If no event occurred by the time of the analysis, then the time to event was censored at the date of the last assessment (tumor assessment/visit) of the patient in question. -Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).

Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death; Patients alive at the time of the analysis were censored on the date last known to be alive.

Disease Free Specific Survival (DFSS) was defined as the interval from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).

Distant Metastasis Free Survival (DMFS) was defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurred first. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).

Health-related quality of life [ Time Frame: At various protocol-defined timepoints: Week 0, 6, 12, on and the day after the day of treatment administration (TA), at Month 6, 9, 12, 24, at the Concluding visit + 6 months and +12 Months and at disease recurrence ] [ Designated as safety issue: No ]

The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the EQ-5D questionnaire was available in their native language.

Number of subjects with Anti-MAGE-A3 antibody concentrations above the cut-off values [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ] [ Designated as safety issue: No ]

Number of subjects with Anti-MAGE-A3 antibody response [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ] [ Designated as safety issue: No ]

Number of subjects with any adverse events (AEs) [ Time Frame: Up to 30 days after each study dose ] [ Designated as safety issue: No ]

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Number of subjects with any serious adverse events (SAEs) [ Time Frame: Up to 30 days after the last administration of study treatment ] [ Designated as safety issue: No ]

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Number of subjects with potential immune-mediated diseases (pIMDs) [ Time Frame: Up to 30 days after the last administration of study treatment ] [ Designated as safety issue: No ]

Mediated Disorders (pIMDs) were to be collected up to 5 years after first treatment administration or study withdrawal.

Occurrence of adverse events including abnormal haematological and biochemical parameters. [ Time Frame: Up to 30 days after each study dose. ] [ Designated as safety issue: Yes ]

Occurrence of serious adverse events and autoimmunity events. [ Time Frame: During the whole study duration up to 30 days after the last administration of study treatment. ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

The patient must have been surgically rendered free of disease before the randomization.

Patient is ≥ 18 years old at the time of signing the informed consent form.

The patient's lymph node tumor shows expression of the MAGE-A3 gene.

The patient has fully recovered from surgery.

ECOG performance status of 0 or 1 at the time of randomization.

The patient must have adequate organ functions as assessed by standard laboratory criteria.

If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.

In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

Exclusion Criteria:

The patient suffers from a mucosal or ocular melanoma.

The patient has or has had any history of in-transit metastases

The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.

The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.

Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.

The patient has a history of autoimmune disease.

The patient has a family history of congenital or hereditary immunodeficiency.

The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.

History of allergic disease or reactions likely to be exacerbated by any component of the treatments.

The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.

The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.

The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.

The patient has an uncontrolled bleeding disorder.

For female patients: the patient is pregnant or lactating.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects